Vitros Chemistry Products Calibrator Kit 20
Brand(s)
Summary
Review/post notice (forward if product is distributed), discontinue/discard inventory, return reply form.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vitros Chemistry Products Calibrator Kit 20 | 2022 | 680 1704 |
Issue
The Vitros Chemistry Products Calibrator Kit 20 is used to calibrate Microtip assays C3, C4, IgM, IgA, IgG, and transferrin. Vitros Calibrator Kit 20 contains five calibrator levels. Although lot 2022 met all initial release criteria, vial to vial variability was subsequently observed during routine internal testing. This prompted an investigation that confirmed that the level 5 calibrator exhibited vial to vial variability which may cause a bias for all six affected assays, although to varying magnitudes.
Recall start date: May 9, 2023
Additional information
Details
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
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